A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation

NCT ID: NCT03783884

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 223 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-14
• Study Completion Date: 2023-01-27

Brief Summary

This clinical investigation is an open-label, multi-center RCT to demonstrate the safety and effective performance of the Lungpacer DPTS (plus standard of care) as compared to Control (standard of care only) in patients aged 18 years or older who are receiving mechanical ventilation. Eligible Subjects will have received mechanical ventilation for ≥96 hours (4 days) and have failed two weaning attempts.

The goal or outcome is to show a numerically greater proportion of subjects weaned in the Treatment (Lungpacer DPTS) group as compared to the Control group.

Detailed Description

The intended patient population is applicable for Lungpacer DPT because there are no noninvasive alternative treatments for patients who are difficult to wean from MV (i.e., ≥96 hours (4 days) on MV) or who have required prolonged MV (>7 days). The intended patient population includes approximately one-third of all patients on mechanical ventilation. Under standard of care, approximately 50% of these patients will recover from mechanical ventilation (Jung, 2016). Standard of care involves daily weaning attempts, known as Spontaneous Breathing Trials (SBTs) or Ventilator Liberation Trials (VLTs) that are intended to encourage diaphragm use and strengthening over time.Therefore, Lungpacer DPT efficacy evaluation must be compared to standard of care in a Control group. Lack of recovery from mechanical ventilation may be due to the inability of a patient to participate in VLTs or weaning attempts, due to extensive diaphragm weakness or sedation, the inability of VLTs to induce sufficient diaphragm strengthening, or co-morbidities that prevent recovery.

Conditions

Ventilator Induced Diaphragm Dysfunction

Keywords

VIDD; Diaphragm Atrophy; Weaning Failure; VLT; SBT; VILI; Phrenic Nerve Stimulation; Maximal Inspiratory Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Subject receives Lungpacer Catheter for transvenous phrenic nerve stimulation to deliver Diaphragm Pacing Therapy Sessions. DPT sessions are 6 sets of 10, delivered twice daily, for a total of 120 stimulation reps per day, plus standard of care for weaning from mechanical ventilation.

Group Type: ACTIVE_COMPARATOR

Lungpacer Diaphragm Pacing Therapy

Intervention Type: DEVICE

Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Control

Subject does not receive Lungpacer Catheter or DPT. Subject receives only Standard of care for weaning from mechanical ventilation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lungpacer Diaphragm Pacing Therapy

Transvenous phrenic nerve stimulation to induce diaphragm contraction.

Intervention Type: DEVICE

Other Intervention Names

Lungpacer DPTS; AeroPace System

Eligibility Criteria

Inclusion Criteria

1. Are 18 years or older, and,

2. Have been mechanically ventilated for ≥96 hours (4 days), and,

3. Have satisfied the Readiness-to-Wean criteria, and,

4. Have failed at least 2 weaning attempts (that were conducted at least 48 hours after initiation of MV, and, that were conducted on different calendar days, and, at least one of which was the protocol-specific Ventilator Liberation Trial).

Exclusion Criteria

1. MIP (absolute value) >50 cm H2O;

2. Invasive mechanical ventilation >90 days;

3. Currently on ECMO;

4. Weaning failure due to hypervolemia;

5. Medical history (including imaging) or known anatomy that prevents percutaneous insertion of the Catheter into the intended thoracic vein on the left side.

6. Clinically overt congestive heart failure that is preventing weaning;

7. Currently being treated with neuromuscular blockade;

8. Pre-existing neurological, neuromuscular or muscular disorder that could affect the respiratory muscles;

9. Pre-existing severe chronic pulmonary fibrosis;

10. Pleural effusions occupying greater than one third of the pleural space on either side;

11. BMI >45 kg/m2;

12. Known or suspected phrenic nerve paralysis;

13. Any electrical device (implanted or external) that may be prone to interaction with, or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators;

14. Current hemodynamic instability, sepsis or septic shock;

15. Prior bacteremia reported within the last 48 hours;

16. Anticipating withdrawal of life support and/or shift to palliation as the goal of care;

17. Known or suspected to be pregnant or lactating;

18. Currently being treated in another clinical trial studying an experimental treatment that could affect the study primary outcome.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lungpacer Medical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University Medical Center

Stanford, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

University of Florida, Shands

Gainesville, Florida, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

U of Illinois at Chicago

Chicago, Illinois, United States

Edward Hines VA Hospital

Hines, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

University of Louisville

Louisville, Kentucky, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

CHI Health Creighton University Medical Center - Bergan Mercy

Omaha, Nebraska, United States

Englewood Hospital Medical Center

Englewood, New Jersey, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Kent County Memorial Hospital

Warwick, Rhode Island, United States

Prisma Health Baptist Hospital

Columbia, South Carolina, United States

University of Texas Southwestern, Zale Lipshy Hospital

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

CHU Angers

Angers, , France

CHU Montpellier

Montpellier, , France

Hôpital La Pitié-Salpêtrière

Paris, , France

CHU Strasbourg

Strasbourg, , France

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Berlin Charite Mitte

Berlin, , Germany

KEM Essen

Essen, , Germany

SLK Löwenstein

Löwenstein, , Germany

Nürnberg Klinikum Nord

Nuremberg, , Germany

FKKG Schmallenberg

Schmallenberg, , Germany

Solingen Krankenhaus Bethanien

Solingen, , Germany

Countries

United States; France; Germany

References

Dres M, Ewert R, Conrad SA, Ataya A, Shrager J, Mortaza S, Delamaire F, Nilius G, Heine A, Mehta N, Ways J, Evans D, Paulon G, Khandwala F, Berry N, Viele K, Nelson T, Gilbertson M, Similowski T, Gama de Abreu M, Goligher EC; RESCUE-3 Trial Investigators. Temporary Transvenous Diaphragm Neurostimulation for Weaning from Mechanical Ventilation (RESCUE-3). Am J Respir Crit Care Med. 2025 Jun 11. doi: 10.1164/rccm.202505-1056OC. Online ahead of print.

Reference Type: DERIVED

PMID: 40498082 (View on PubMed)

Related Links

http://lungpacer.com

Sponsor website

Other Identifiers

P-300

Identifier Type: -

Identifier Source: org_study_id